Model Number 71702-01 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091)
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Event Date 11/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturer date for the reported sensor is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
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Event Description
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A customer reported experiencing he developed an infection with the past 3 after wearing freestyle libre sensors he has worn.Specific to the sensor being reported, the customer indicated he observed a "wound with moisture coming out" at the sensor site and stated the "skin was hard, swollen, and painful".Customer had contact with a healthcare professional and was prescribed flucloxacillin (oral antibiotic) for treatment.No death or permanent injury was reported related to this event.
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Manufacturer Narrative
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No product has been returned.Extended investigation has been performed for the reported complaint and it has been determined that there was no indication that the product did not meet specification.Dhrs (device history review) for the freestyle libre sensor and freestyle libre sensor kit were reviewed and the dhrs showed the freestyle libre sensor and freestyle libre sensor kit passed all tests prior to release.Dose audit reports were reviewed and demonstrates the continued effectiveness of the established sterilization process for libre sensor kits.Environmental monitoring reports were reviewed, including bioburden and endotoxin testing, and demonstrated that all monitoring processes continue to meet adc minimum requirements for product quality.The dose audit report covers the required time period.All review activities conducted above, including but not limited to the final release testing specifically associated with the manufacture of this product, are sufficient information in order to show if the product has met specifications prior to release.If the product is returned, the case will be re-opened and a physical investigation will be performed.
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Event Description
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A customer reported experiencing he developed an infection with the past 3 after wearing freestyle libre sensors he has worn.Specific to the sensor being reported, the customer indicated he observed a "wound with moisture coming out" at the sensor site and stated the "skin was hard, swollen, and painful".Customer had contact with a healthcare professional and was prescribed flucloxacillin (oral antibiotic) for treatment.No death or permanent injury was reported related to this event.
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Search Alerts/Recalls
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